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Oral Forodesine Hydrochloride (BCX-1777) in Patients With Recurrent or Refractory T/NK-cell Malignancies

NCT ID: NCT00823355

Last Updated: 2013-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Brief Summary

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Primary objectives are to evaluate the safety profile and tolerability of oral BCX1777 in each cohort of patients with recurrent or refractory T/NK-cell malignancies and to evaluate pharmacokinetics (PK) of oral BCX1777.

Detailed Description

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Conditions

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Recurrent or Refractory T/NK-cell Malignancies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BCX1777

Group Type EXPERIMENTAL

forodesine hydrochloride

Intervention Type DRUG

Cohort 1: 100mg / body (1 x 100mg tablet once daily)

forodesine hydrochloride

Intervention Type DRUG

Cohort 2: 200mg / body (2 x 100mg tablets once daily)

forodesine hydrochloride

Intervention Type DRUG

Cohort 3: 300mg / body (3 x 100mg tablets once daily)

forodesine hydrochloride

Intervention Type DRUG

Cohort 4: 400mg / body (4 x 100mg tablets once daily)

Interventions

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forodesine hydrochloride

Cohort 1: 100mg / body (1 x 100mg tablet once daily)

Intervention Type DRUG

forodesine hydrochloride

Cohort 2: 200mg / body (2 x 100mg tablets once daily)

Intervention Type DRUG

forodesine hydrochloride

Cohort 3: 300mg / body (3 x 100mg tablets once daily)

Intervention Type DRUG

forodesine hydrochloride

Cohort 4: 400mg / body (4 x 100mg tablets once daily)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Histologically documented with histopathological diagnosis from biopsy, T/NK-cell malignancies (WHO classification). Precursor T-cell lymphoblastic leukemia/lymphoma (T-ALL/T-LBL) should be excluded in this study
* A patient with recurrent, relapse or refractory T/NK-cell malignancies who has received at lease one chemotherapeutic regimen
* Age 20 or greater
* Eastern Cooperative Oncology Group(ECOG) performance status:0,1.
* Able to be hospitalized at least for 15 days from the first dose
* In the case of subject with tumor cell rate of ≤25% in bone marrow, a patient who satisfies both of the following criteria.

* Neutrophil count: ≥1,200/mm3
* Platelet count: ≥75,000/mm3

* In the case of CTCL, the tumor cell rate is handled as ≤25%.
* Adequate Liver function: AST, ALT ≤ 5.0 x upper limit of normal (ULN)
* Adequate Renal function: Creatinine Clearance (using cockcroft-Gault formula) ≥ 50mL/min
* Life expectancy of at least 3 months
* A patient who has given a written informed consent prior to the start of procedures proper to this study.

Exclusion Criteria

\-
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mundipharma K.K.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Investigational Site

Nagoya, Aichi-ken, Japan

Site Status

Investigational Site

Nagasaki, Nagasaki, Japan

Site Status

Investigational Site

Cyuo, Tokyo, Japan

Site Status

Countries

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Japan

References

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Ogura M, Tsukasaki K, Nagai H, Uchida T, Oyama T, Suzuki T, Taguchi J, Maruyama D, Hotta T, Tobinai K. Phase I study of BCX1777 (forodesine) in patients with relapsed or refractory peripheral T/natural killer-cell malignancies. Cancer Sci. 2012 Jul;103(7):1290-5. doi: 10.1111/j.1349-7006.2012.02287.x. Epub 2012 Apr 30.

Reference Type DERIVED
PMID: 22448814 (View on PubMed)

Other Identifiers

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BCX1777-J01

Identifier Type: -

Identifier Source: org_study_id